Meningococcal DiseasePhase 2/3NCT01148524

Assessment of Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10

A Phase 2/3 study testing No Vaccine and rMenB+OMV-NZ in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 6 sites in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713). Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined… Read more about this study

Who is it for?: Ages 13 to 19 yearsHealthy volunteers can take part
Conditions the study is for: Meningococcal Disease, Meningococcal Meningitis
What is being tested?: No Vaccine and rMenB+OMV-NZ
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 817 participants
Where: 6 sitesChile
Study dates: Aug 2010to Jan 2012
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 to 19 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained.
Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age).
For Minor subjects:
subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.
For Adult subjects:
subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.

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Were available for the visit scheduled in the study.
Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.
Inclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):
For Minor subjects: (≤18 years of age)
subjects who had given their written assent and whose parent or legal guardians had given written informed consent at the time of enrollment, after the nature of the study had been explained.
For Adult subjects: (older than 18 years of age)
subjects who had given their written informed consent at the time of enrollment, after the nature of the study had been explained.
Who had participated in the V72P10 study and had received their last vaccination 18 months (-30 + 90 days) before enrollment in V72P10E1.
Who had completed the vaccination course in study V72P10, according to the protocol.
Who had provided at least the blood sample one month after the last vaccination in V72P10 (blood sample at visit 6, month 7), according to the protocol.
Were available for the study visit scheduled in the study.
Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.

Who cannot join

For Minor subjects:
subjects who were unwilling or unable to give written informed assent to participate in the study, and whose parent(s)/legal guardian(s) were unwilling or unable to give written informed consent to participate in the study
For Adult subjects:
subjects who were unwilling or unable to give written informed consent to participate in the study.
History of any meningococcal B vaccine administration.
Previous ascertained or suspected disease caused by N. meningitidis.

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Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
Antibiotic treatment within 6 days prior to enrollment.
Any serious chronic or progressive disease according to the judgment of the investigator (e.g., neoplasm, diabetes mellitus Type I, cardiac disease, hepatic disease, neurological disease or seizure, either associated with fever or as part of an underlying neurological disorder or syndrome, autoimmune disease, HIV infection or AIDS, or blood dyscrasias or diathesis, signs of cardiac or renal failure or severe malnutrition).
Known or suspected impairment/alteration of the immune system, immunosuppressive therapy, use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within 30 days prior to enrollment (use of low or moderate doses of inhaled steroids is not an exclusion);
Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days prior to enrollment.
Participation in another clinical trial within 90 days prior to enrollment or planned for during study.
Family members and household members of study staff.
Any condition which, in the opinion of the investigator, could have interfered with the evaluation of the study objectives.
Exclusion criteria for subjects who participated in the V72P10 study (follow-on subjects):
Exclusion criteria were the same as for naïve subjects, with the exception of criterion 2.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

Chile6 sites

Centro de Salud Lo Barnechea
Santiago
Centro para vacunas en desarrollo. Hospital de Niños Roberto del Río
Santiago
Escuela de Medicina de la Universidad de Valparaíso
Santiago
Hospital Luis Calvo Mackenna
Santiago
Liceo Jose Victorino Lastarria
Santiago
Universidad de Chile. Facultad de Medicina
Santiago

Other trials in Chile

About this study

Official title: A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).

Subjects who participated in study V72P10, and who meet all other enrollment criteria for this extension study, and a group of naïve subjects (defined as subjects who had never received rMenB+OMV NZ or other experimental MenB vaccines) of similar age to the subjects who were eligible to participate in this extension study, performed one study visit in which a single blood sample was drawn for MenB serological analyses.

Conditions: Meningococcal Disease, Meningococcal Meningitis
Being tested: No Vaccine, rMenB+OMV-NZ
Keywords: Meningococcal disease, Vaccines, Adolescents
Medical subject headings: Meningococcal Infections, Meningitis, Meningococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

No VaccineBiological
rMenB+OMV-NZBiological
Also called Serogroup B meningococcal recombinant vaccine
Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).

Study groups in NCT01148524
Study group	Role	What they receive
rMenB06	Other	Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB0	Other	Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB016	Other	Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB01	Other	Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 month) and placebo (at 2 and 6 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB026	Other	Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB02	Other	Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB012	Other	Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and 1 dose of placebo (at 6 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
rMenB6	Other	Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study had a blood draw. Receives: Biological: rMenB+OMV-NZ
Naive	Other	An additional study group of naïve subjects that served as a baseline comparator for assessing antibody persistence in the vaccine groups and had blood draw for serological analyses at the time of enrollment. Receives: Biological: No Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).
Measured: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
Measured: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.
The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.
Measured: month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.
Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
Measured: 18 months after last vaccination V72P10 study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Jan 2012

First posted22 Jun 2010 (estimated)
Study startAug 2010
Primary completionJan 2012
Study completionJan 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 817 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01148524
Sponsor's protocol ID: V72P10E1
Status last verified: May 2018
First submitted: 4 Jun 2010
Last updated: 15 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Meningococcal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2b/3, Multi-Center, Extension Study of V72P10 to Assess Antibody Persistence at Eighteen Months After the Completion of the Vaccination Course in Study V72P10.
ClinicalTrials.gov ID: NCT01148524
Acronym / sponsor ID: V72P10E1
Conditions: Meningococcal Disease, Meningococcal Meningitis
Keywords: Meningococcal disease, Vaccines, Adolescents
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 817 participants (actual)
Lead sponsor: Novartis VaccinesIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Jan 2012 (actual)
Study completion: Jan 2012 (actual)
First posted: 22 Jun 2010 (estimated)
Results: Posted 11 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This was a Phase 2b/3, multi-center, extension study of V72P10 to assess antibody persistence at 18 months after the vaccination course in study V72P10 (NCT00661713).

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 9

Arm	Type	Receives
rMenB06	Other	Biological: rMenB+OMV-NZSubjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study had a blood draw.
rMenB0	Other	Biological: rMenB+OMV-NZSubjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study had a blood draw.
rMenB016	Other	Biological: rMenB+OMV-NZSubjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study had a blood draw.
rMenB01	Other	Biological: rMenB+OMV-NZSubjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 month) and placebo (at 2 and 6 months) in V72P10 study had a blood draw.
rMenB026	Other	Biological: rMenB+OMV-NZSubjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study had a blood draw.
rMenB02	Other	Biological: rMenB+OMV-NZSubjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study had a blood draw.
rMenB012	Other	Biological: rMenB+OMV-NZSubjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and 1 dose of placebo (at 6 months) in V72P10 study had a blood draw.
rMenB6	Other	Biological: rMenB+OMV-NZSubjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study had a blood draw.
Naive	Other	Biological: No VaccineAn additional study group of naïve subjects that served as a baseline comparator for assessing antibody persistence in the vaccine groups and had blood draw for serological analyses at the time of enrollment.

Who may qualify

Ages: 13 to 19 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (18 listed)

Informed consent was obtained from all the subjects before enrollment into the study after the nature of the study had been explained.
Healthy adolescents, 13-19 years of age (the age window is defined as the first day the subject turns 13 years of age up to the day before the subject turns 20 years of age).
For Minor subjects:
Were available for the visit scheduled in the study.
Were in good health as determined by medical history, physical examination, clinical judgment of the investigator.

Key exclusion criteria (16 listed)

For Minor subjects:
History of any meningococcal B vaccine administration.
Previous ascertained or suspected disease caused by N. meningitidis.
Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis.
Antibiotic treatment within 6 days prior to enrollment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
No Vaccine	Biological	Naive
rMenB+OMV-NZAlso: Serogroup B meningococcal recombinant vaccineSubjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).	Biological	rMenB0, rMenB01, rMenB012, rMenB016, rMenB02, rMenB026, rMenB06, rMenB6

Primary outcome

Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
Time frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.
The immune response was measured as the percentage of subjects with hSBA titers ≥1:4 against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study, evaluated by serum bactericidal assay using human complement (hSBA).
Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
Time frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.
The immune response was measured as the hSBA geometric mean titers (GMTs) directed against meningococcal strains 44/76-SL, 5/99 and NZ98/254, at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.
Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.
Time frame: month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.
The immune response was measured as the geometric mean ratio (GMRs) of hSBA GMTs against meningococcal strains 44/76-SL, 5/99 and NZ98/254 as follow: GMTs at 1 month after last vaccination to baseline GMTs; GMTs at 18 months after last vaccination to baselines GMTs; and GMTs at 18 months after last vaccination to GMTs at 1 month after last vaccination.
Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.
Time frame: 18 months after last vaccination V72P10 study.
The immune response was measured as the geometric mean concentrations (GMCs) directed against meningococcal 287-953 antigen, evaluated using enzyme-linked immunosorbent assay (ELISA), at 18 months after month-6 vaccination of rMenB+OMV-NZ or placebo in V72P10 study, and in age-matched vaccine naive subjects enrolled in this study.

Results and safety

Results posted to the registry on 11 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
rMenB06	49	49
rMenB0	95	95
rMenB016	53	53
rMenB01	102	102
rMenB026	57	57
rMenB02	106	106
rMenB012	153	153
rMenB6	51	51
Naive	151	151

Primary outcome: Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.

Time frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.. Number (95% Confidence Interval). Unit: Percentage of subjects

Measure	rMenB06 n = 49	rMenB0 n = 95	rMenB016 n = 53	rMenB01 n = 102	rMenB026 n = 57	rMenB02 n = 106	rMenB012 n = 153	rMenB6 n = 51	Naive n = 151
S.44/76-SL-bl (N=49,95,53,102,57,106,153,51,0)	31 (18 to 45)	40 (30 to 51)	40 (26 to 54)	32 (23 to 42)	32 (20 to 45)	41 (31 to 51)	44 (36 to 52)	47 (33 to 62)	NA (NA to NA)
S.44/76-SL-1m (N=49,95,53,102,57,106,153,51,0)	100 (93 to 100)	93 (85 to 97)	100 (93 to 100)	100 (96 to 100)	100 (94 to 100)	100 (97 to 100)	100 (98 to 100)	94 (84 to 99)	NA (NA to NA)
S.44/76-SL-18m	84 (70 to 93)	73 (63 to 81)	92 (82 to 98)	82 (74 to 89)	86 (74 to 94)	81 (72 to 88)	83 (76 to 89)	73 (58 to 84)	50 (42 to 59)
S.5/99-bl (N=49,95,53,102,57,106,153,51,0)	22 (12 to 37)	33 (23 to 43)	28 (17 to 42)	26 (18 to 36)	21 (11 to 34)	30 (22 to 40)	34 (27 to 42)	33 (21 to 48)	NA (NA to NA)
S.5/99-1m (N=49,95,53,102,57,106,153,51,0)	98 (89 to 100)	96 (90 to 99)	100 (93 to 100)	100 (96 to 100)	100 (94 to 100)	100 (97 to 100)	100 (98 to 100)	88 (76 to 96)	NA (NA to NA)
S.5/99-18m	94 (83 to 99)	65 (55 to 75)	98 (90 to 100)	93 (86 to 97)	100 (94 to 100)	95 (89 to 98)	96 (92 to 99)	73 (58 to 84)	25 (18 to 33)
S.NZ98/254-bl (N=49,95,53,102,57,106,153,51,0)	29 (17 to 43)	31 (21 to 41)	32 (20 to 46)	24 (16 to 33)	21 (11 to 34)	30 (22 to 40)	30 (22 to 38)	29 (17 to 44)	NA (NA to NA)
S.NZ98/254-1m (N=49,95,53,102,57,106,153,51,0)	100 (93 to 100)	94 (87 to 98)	100 (93 to 100)	100 (96 to 100)	98 (91 to 100)	100 (97 to 100)	99 (96 to 100)	92 (81 to 98)	NA (NA to NA)

Population analysed: Analysis was performed on the modified intention-to-treat (MITT) data set, i.e. all subjects who provided evaluable serum samples. Samples were collected at 18 months post last vaccination in the parent study. For the Naive group, blood samples were obtained for meningococcal serology at day 1 and served as a comparator.

Primary outcome: Geometric Mean hSBA Titers Directed Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.

Time frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.. Geometric mean (95% Confidence Interval). Unit: Geometric mean titers

Measure	rMenB06 n = 49	rMenB0 n = 95	rMenB016 n = 53	rMenB01 n = 102	rMenB026 n = 57	rMenB02 n = 106	rMenB012 n = 153	rMenB6 n = 51	Naive n = 151
S.44/76-SL-bl (N=49,95,53,102,57,106,153,51,0)	2.83 (1.85 to 4.31)	3.75 (2.75 to 5.12)	3.56 (2.37 to 5.34)	2.74 (2.04 to 3.68)	2.76 (1.86 to 4.1)	3.24 (2.43 to 4.34)	3.86 (3.02 to 4.93)	4.33 (2.86 to 6.56)	NA (NA to NA)
S.44/76-SL-1m (N=49,95,53,102,57,106,153,51,0)	227 (161 to 320)	47 (36 to 60)	316 (227 to 439)	189 (149 to 241)	265 (192 to 365)	227 (179 to 287)	253 (208 to 309)	62 (44 to 86)	NA (NA to NA)
S.44/76-SL-18m	27 (16 to 45)	16 (11 to 23)	50 (30 to 83)	29 (20 to 42)	44 (27 to 73)	34 (24 to 49)	42 (31 to 56)	19 (12 to 32)	4.52 (3.52 to 5.82)
S.5/99-bl (N=49,95,53,102,57,106,153,51,0)	2.31 (1.62 to 3.3)	2.65 (2.04 to 3.44)	2.55 (1.81 to 3.6)	2.22 (1.73 to 2.85)	1.72 (1.23 to 2.39)	2.36 (1.84 to 3.01)	2.63 (2.14 to 3.23)	2.67 (1.88 to 3.79)	NA (NA to NA)
S.5/99-1m (N=49,95,53,102,57,106,153,51,0)	802 (574 to 1121)	63 (49 to 81)	1181 (856 to 1630)	445 (352 to 562)	1105 (808 to 1510)	727 (577 to 916)	605 (499 to 735)	68 (49 to 94)	NA (NA to NA)
S.5/99-18m	65 (43 to 98)

Primary outcome: Geometric Mean Ratio at 18 Months After Month-6 Vaccination, Over Baselines at Month 0 and at One Month After the Last rMenB+OMV-NZ Vaccination in the V72P10 Study.

Time frame: month 0 (baseline), month 1 and 18 months after last vaccination in V72P10 study.. Geometric mean (95% Confidence Interval). Unit: Geometric mean ratio

Measure	rMenB06 n = 49	rMenB0 n = 95	rMenB016 n = 53	rMenB01 n = 102	rMenB026 n = 57	rMenB02 n = 106	rMenB012 n = 153	rMenB6 n = 51
S.44/76-SL (1 m postvaccination to baseline)	80 (53 to 122)	12 (9.18 to 17)	89 (60 to 133)	69 (52 to 92)	96 (65 to 141)	70 (52 to 93)	66 (52 to 83)	14 (9.47 to 21)
S.44/76-SL (18 m postvaccination to baseline)	9.51 (5.93 to 15)	4.26 (3.01 to 6.03)	14 (8.95 to 22)	11 (7.6 to 15)	16 (10 to 25)	11 (7.67 to 15)	11 (8.2 to 14)	4.46 (2.8 to 7.11)
S.44/76-SL (18 m to 1 m postvaccination)	0.12 (0.077 to 0.18)	0.34 (0.25 to 0.47)	0.16 (0.1 to 0.24)	0.15 (0.11 to 0.21)	0.17 (0.11 to 0.25)	0.15 (0.11 to 0.21)	0.16 (0.13 to 0.21)	0.31 (0.2 to 0.48)
S.5/99 (1 m postvaccination to baseline)	347 (223 to 541)	24 (17 to 33)	462 (301 to 709)	200 (147 to 273)	644 (425 to 976)	309 (227 to 419)	230 (178 to 298)	25 (16 to 39)
S.5/99 (18 m postvaccination to baseline)	28 (18 to 44)	2.68 (1.94 to 3.7)	47 (31 to 73)	18 (13 to 25)	58 (38 to 87)	18 (14 to 25)	28 (21 to 36)	3.69 (2.39 to 5.7)
S.5/99 (18 m to 1 m postvaccination)	0.081 (0.055 to 0.12)	0.11 (0.085 to 0.15)	0.1 (0.071 to 0.15)	0.091 (0.07 to 0.12)	0.09 (0.063 to 0.13)	0.06 (0.046 to 0.078)	0.12 (0.096 to 0.15)

Primary outcome: Geometric Mean Concentration Against Meningococcal 287-953 Antigen, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects.

Time frame: 18 months after last vaccination V72P10 study.. Geometric mean (95% Confidence Interval). Unit: UI/mL

Measure	rMenB06 n = 35	rMenB0 n = 34	rMenB016 n = 35	rMenB01 n = 35	rMenB026 n = 35	rMenB02 n = 35	rMenB012 n = 35	rMenB6 n = 34	Naive n = 35
Value	272 (186 to 397)	55 (37 to 82)	555 (376 to 818)	217 (148 to 319)	490 (333 to 721)	150 (101 to 221)	175 (119 to 256)	59 (40 to 88)	24 (20 to 27)

Population analysed: Analysis was performed on the MITT dataset.

Adverse events

Time frame: 18 months after vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
rMenB06	0 of 49 (0%)	0 of 49 (0%)	Not reported
rMenB0	0 of 95 (0%)	0 of 95 (0%)	Not reported
rMenB016	0 of 53 (0%)	0 of 53 (0%)	Not reported
rMenB01	0 of 102 (0%)	0 of 102 (0%)	Not reported
rMenB026	0 of 57 (0%)	0 of 57 (0%)	Not reported
rMenB02	0 of 106 (0%)	0 of 106 (0%)	Not reported
rMenB012	0 of 153 (0%)	0 of 153 (0%)	Not reported
rMenB6	0 of 51 (0%)	0 of 51 (0%)	Not reported
Naive	0 of 151 (0%)	0 of 151 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Vaccines study chair

Novartis Vaccines

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing No Vaccine and rMenB+OMV-NZ in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis Vaccines at 6 sites in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Subjects With hSBA Titers ≥1:4 Against Meningococcal Strains, At 18 Months After Month-6 Vaccination in V72P10 Study, and in Naive Subjects. (time frame: month 0 (bl=baseline), month 1 and 18 months after last vaccination in V72P10 study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01148524.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.